Proposed Registration Decision PRD2016-09, Metofluthrin

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Pest Management Regulatory Agency
4 March 2016
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2016-9E-PDF (PDF version)

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To obtain a full copy of Proposed Registration Decision PRD2016-09, Metofluthrin, please contact our publications office.

Should you require further information, please contact the Pest Management Information Service.

Summary

Table of Contents

Proposed Registration Decision for Metofluthrin

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act and Regulations, is proposing full registration for the sale and use of SumiOne Technical Grade and OFF! Clip On Mosquito Repellent, containing the technical grade active ingredient metofluthrin, as a personal insect repellent.

SumiOne Technical Grade (Registration Number 30210) and OFF! Clip On Mosquito Repellent (Registration Number 30211) are conditionally registered in Canada. The detailed review for SumiOne Technical Grade and OFF! Clip On Mosquito Repellent can be found in Evaluation Report ERC2015-01, Metofluthrin. The current applications were submitted to convert SumiOne Technical Grade and OFF! Clip On Mosquito Repellent from conditional registration to full registration.

An evaluation of available scientific information found that, under the approved conditions of use, the product has value and does not present an unacceptable risk to human health or the environment.

This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2016-09, Metofluthrin provides detailed technical information on the human health, environmental and value assessments of SumiOne Technical Grade and OFF! Clip On Mosquito Repellent.

What Does Health Canada Consider When Making a Registration Decision?

The key objective of the Pest Control Products Act is to prevent unacceptable risks to people and the environment from the use of pest control products. Health or environmental risk is considered acceptable if there is reasonable certainty that no harm to human health, future generations or the environment will result from use or exposure to the product under its proposed conditions of registration. The Act also requires that products have value when used according to the label directions. Conditions of registration may include special precautionary measures on the product label to further reduce risk.

To reach its decisions, the PMRA applies modern, rigorous risk-assessment methods and policies. These methods consider the unique characteristics of sensitive subpopulations in humans (for example, children) as well as organisms in the environment. These methods and policies also consider the nature of the effects observed and the uncertainties when predicting the impact of pesticides. For more information, please refer to the following:

Before making a final registration decision on metofluthrin, the PMRA will consider any comments received from the public in response to Proposed Registration Decision PRD2016-09, Metofluthrin. The PMRA will then publish a Registration Decision on metofluthrin, which will include the decision, the reasons for it, a summary of comments received on the proposed registration decision and the PMRA's response to these comments.

For more details on the information presented in this summary, please refer to the Science Evaluation of Proposed Registration Decision PRD2016-09, Metofluthrin.

What Is Metofluthrin?

Metofluthrin is an active ingredient which belongs to the pyrethroid class of insecticides and is used to repel mosquitoes. OFF! Clip On Mosquito Repellent is a battery-powered device which contains a metofluthrin-impregnated cartridge. The OFF! Clip On Mosquito Repellent device is worn on the person and functions as a personal insect repellent by vaporising metofluthrin and emitting it over an area large enough to protect the wearer from mosquitoes.

Health Considerations

Can Approved Uses of Metofluthrin Affect Human Health?

OFF! Clip On Mosquito Repellent containing metofluthrin is unlikely to affect your health when used according to label directions.

Potential exposure to metofluthrin may occur when handling or using the product. When assessing health risks, two key factors are considered:

  • the levels where no health effects occur, and
  • the levels to which people may be exposed.

The dose levels used to assess risks are established to protect the most sensitive human population (for example, children and nursing mothers). Only uses for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

Toxicology studies in laboratory animals describe potential health effects from varying levels of exposure to a chemical and identify the dose where no effects are observed. The health effects noted in animals occur at doses more than 100-times higher (and often much higher) than levels to which humans are normally exposed when pesticide-containing products are used according to label directions.

In laboratory animals, metofluthrin was of low acute toxicity by the oral and dermal routes of exposure. It was of slight acute toxicity by the inhalation route of exposure and as such the hazard statement "Caution Poison" is required on the label. Metofluthrin was minimally irritating to the eye, was nonirritating to the skin, and did not cause an allergic skin reaction. Metofluthrin does, however, belong to a class of pesticides that may cause a transient itching, tingling or burning sensation of the skin following skin contact.

OFF! Clip On Mosquito Repellent product consists primarily of metofluthrin; therefore, the toxicity profile and label statements for technical grade metofluthrin are representative of this product.

Registrant-supplied short, and long term (lifetime) animal toxicity tests, as well as information from the published scientific literature were assessed for the potential of metofluthrin to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoints for risk assessment included neurotoxicity characterized by clinical signs. In addition, although there was no evidence of increased susceptibility of the young in the guideline toxicity studies submitted, residual uncertainty remains since young animals have differences (such as the age-dependent maturation of key metabolic processes) that may lead to increased susceptibility of the young to pyrethroid toxicity. There was also evidence of effects on the liver. Longer-term dosing with metofluthrin resulted in liver tumours in rats, but not in mice. The risk assessment protects against the effects noted above by ensuring that the level of exposure to humans is well below the lowest dose at which these effects occurred in animal tests.

Risks in Residential Environments

Estimated risk for residential exposure is not of concern provided that directions specified on the label are observed.

For the original residential exposure review of metofluthrin, please see ERC2015-01. Two data requirements were identified during the original review, a new passive dosimetry study and a new in vivo dermal absorption study. The risk assessment has been updated and all data requirements have now been satisfied.

A risk assessment conducted for individuals handling, or those in the vicinity of the OFF! Clip On Mosquito Repellent device, indicated that risks to adults, youth and children are not of concern when the product is used according to label directions.

Environmental Considerations

What Happens When Metofluthrin is Introduced into the Environment?

OFF! Clip On Mosquito Repellent will not pose an unacceptable risk to non-target aquatic and terrestrial organisms.

Metofluthrin enters the environment when used as an insect repellent in a personal device, which allows the active ingredient to vaporize into the air. Significant deposition of metofluthrin in the environment is unlikely due to the volatile nature of the compound, rapid transformation processes in soil, and limited use pattern.

Metofluthrin is highly toxic to aquatic invertebrates, fish, and bees. But the exposure of these nontarget organisms to metofluthrin is, however, unlikely based on the use pattern.

Value Considerations

What Is the Value of OFF! Clip On Mosquito Repellent?

OFF! Clip On Mosquito Repellent is a personal insect repellent device that provides protection from mosquitoes for up to 12 hours.

Mosquitoes are an outdoor nuisance pest across all of Canada, especially in the morning and evening. Mosquito bites can cause discomfort and irritation, and can vector diseases such as West Nile Virus. In addition to health risks associated with mosquito bites, annoyance from mosquitoes can reduce the enjoyment of being outdoors and cause people to avoid outdoor activities when mosquito populations are heavy.

While no additional value data were required to convert the end-use product OFF! Clip On Mosquito Repellent from conditional to full registration, data was submitted to support an increase in the protection time from 11 to up to 12 hours.

Measures to Minimize Risk

Labels of registered pesticide products include specific instructions for use. Directions include risk-reduction measures to protect human and environmental health. These directions must be followed by law.

The key risk-reduction measures being proposed on the label of OFF! Clip On Mosquito Repellent to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

For OFF! Clip On Mosquito Repellent the hazard statement "Caution Poison" is required on the product label. The label states to keep out of reach of children and thus, it is considered unlikely for youth and children to replace the cartridge (refill disk); however, to exclude this activity from being considered in the risk assessment for youth, the following statement is on the label "only adults are permitted to replace the refill disk." In addition, a statement identifying the device should not be worn while barbecuing is required.

Environment

Key risk-reduction measures for the protection of the environment include the precautionary label statement:

  • Toxicity statement for aquatic organisms

Next Steps

Before making a final registration decision on metofluthrin, the PMRA will consider any comments received from the public in response to Proposed Registration Decision PRD2016-09, Metofluthrin. The PMRA will accept written comments on PRD2016-09, Metofluthrin up to 45 days from the date of publication of PRD2016-09. Please forward all comments to Publications. The PMRA will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed decision and the Agency's response to these comments.

Other Information

When the PMRA makes its registration decision, it will publish a Registration Decision on metofluthrin (based on the Science Evaluation of PRD2016-09, Metofluthrin). In addition, the test data referenced in PRD2016-09 will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).

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